Comparison of Fixed-dose Combinations of Amlodipine/Losartan Potassium/Chlorthalidone and Amlodipine/Losartan Potassium in Patients With Stage 2 Hypertension Inadequately Controlled With Amlodipine/Losartan Potassium: A Randomized, Double-blind, Multicenter, Phase III Study

Soon Jun Hong, Han Saem Jeong, Seung Hwan Han, Ki Yuk Chang, Bum Kee Hong, Bong Ki Lee, Shung Chull Chae, Woo Shik Kim, Chang Gyu Park, Jung Ho Heo, Seung Uk Lee, Young Dae Kim, Kee Sik Kim, Jung Hyun Choi, Hyun Jae Kang, Jae Joong Kim, Seok Min Kang, Young Jin Choi, Joon Han Shin, Kook Jin ChunDong Gu Shin, Seong Hoon Park, Jun Kwan, Yu Jeong Choi, Myung Ho Jeong, Jei Keon Chae, Dong Woon Kim, Jung Rae Cho, Kyoo Rok Han, Kyung Heon Won, Sang Ho Park, Sang Kon Lee, Sang Hoon Kim, Jina Jung, Cheol Ho Kim

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Purpose The goal of this study was to compare the efficacy and safety of fixed-dose combinations of amlodipine/losartan potassium/chlorthalidone (A/L/C) and A/L in Korean patients with stage 2 hypertension inadequately controlled by A/L. Methods This study was an 8-week, randomized double-blind, multicenter, phase III clinical trial. Three hundred forty volunteer patients with stage 2 hypertension were randomized to receive A/L/C or A/L. The primary end point was a change in sitting systolic blood pressure (SitSBP) after 8 weeks of treatment. As secondary end points, the change in SitSBP after 2 weeks of treatment and the change in sitting diastolic blood pressure (SitDBP) were compared between treatment groups. All patients were assessed for adverse events, clinical laboratory data, and vital signs. Findings Of 330 patients from 33 medical centers, 328 patients who had available efficacy data were analyzed. After 8 weeks of double-blind treatment, the mean (SD) changes in SitSBP at 8 weeks were −16.4 (0.9) mm Hg and −6.9 (1.0) mm Hg in the A/L/C and A/L groups, respectively. A/L/C had a statistically superior blood pressure–lowering effect compared with that of A/L (mean [SD] difference, 9.5 [1.3] mm Hg; P < 0.001). The mean (SD) change in SitDBP at 8 weeks was significantly greater with A/L/C (−8.0 [0.6] mm Hg) than with A/L (−3.6 [0.6] mm Hg) (P <.001). In terms of the mean (SD) change in SitDBP at 2 weeks compared with baseline, A/L/C (−5.9 [0.5] mm Hg) was statistically different from A/L (−2.9 [0.5] mm Hg) (P <.001). Mean (SD) SitSBP change from baseline to week 2 was −13.2 (0.9) and −5.5 (0.9) in the A/L/C and A/L groups, respectively, with a statistically significant blood pressure–lowering effect (P < 0.001). The number of participants who achieved target blood pressure at week 8 was significantly higher in the A/L/C group (93 patients [55.7%]) than in the A/L group (48 [29.8%]) (P < 0.001). Adverse drug reactions were observed in 23 patients (7.0%), and the incidence of dizziness was significantly higher in the A/L/C group than in the A/L group (4.8% vs 0.6%, P = 0.037) There were no serious adverse events associated with the study drugs. Implications The results of this study suggest that A/L/C had a significantly increased blood pressure–lowering efficacy compared with that of A/L and had a good safety profile. ClinicalTrials.gov identifier: NCT02916602.

Original languageEnglish
Pages (from-to)2049-2060
Number of pages12
JournalClinical Therapeutics
Volume39
Issue number10
DOIs
Publication statusPublished - 2017 Oct

Fingerprint

Chlorthalidone
Amlodipine
Losartan
Blood Pressure
Hypertension
Safety
Phase III Clinical Trials
Vital Signs
Dizziness

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Pharmacology (medical)

Cite this

Hong, Soon Jun ; Jeong, Han Saem ; Han, Seung Hwan ; Chang, Ki Yuk ; Hong, Bum Kee ; Lee, Bong Ki ; Chae, Shung Chull ; Kim, Woo Shik ; Park, Chang Gyu ; Heo, Jung Ho ; Lee, Seung Uk ; Kim, Young Dae ; Kim, Kee Sik ; Choi, Jung Hyun ; Kang, Hyun Jae ; Kim, Jae Joong ; Kang, Seok Min ; Choi, Young Jin ; Shin, Joon Han ; Chun, Kook Jin ; Shin, Dong Gu ; Park, Seong Hoon ; Kwan, Jun ; Choi, Yu Jeong ; Jeong, Myung Ho ; Chae, Jei Keon ; Kim, Dong Woon ; Cho, Jung Rae ; Han, Kyoo Rok ; Won, Kyung Heon ; Park, Sang Ho ; Lee, Sang Kon ; Kim, Sang Hoon ; Jung, Jina ; Kim, Cheol Ho. / Comparison of Fixed-dose Combinations of Amlodipine/Losartan Potassium/Chlorthalidone and Amlodipine/Losartan Potassium in Patients With Stage 2 Hypertension Inadequately Controlled With Amlodipine/Losartan Potassium : A Randomized, Double-blind, Multicenter, Phase III Study. In: Clinical Therapeutics. 2017 ; Vol. 39, No. 10. pp. 2049-2060.
@article{4389e40d4f534687b2f8209e5d19de8e,
title = "Comparison of Fixed-dose Combinations of Amlodipine/Losartan Potassium/Chlorthalidone and Amlodipine/Losartan Potassium in Patients With Stage 2 Hypertension Inadequately Controlled With Amlodipine/Losartan Potassium: A Randomized, Double-blind, Multicenter, Phase III Study",
abstract = "Purpose The goal of this study was to compare the efficacy and safety of fixed-dose combinations of amlodipine/losartan potassium/chlorthalidone (A/L/C) and A/L in Korean patients with stage 2 hypertension inadequately controlled by A/L. Methods This study was an 8-week, randomized double-blind, multicenter, phase III clinical trial. Three hundred forty volunteer patients with stage 2 hypertension were randomized to receive A/L/C or A/L. The primary end point was a change in sitting systolic blood pressure (SitSBP) after 8 weeks of treatment. As secondary end points, the change in SitSBP after 2 weeks of treatment and the change in sitting diastolic blood pressure (SitDBP) were compared between treatment groups. All patients were assessed for adverse events, clinical laboratory data, and vital signs. Findings Of 330 patients from 33 medical centers, 328 patients who had available efficacy data were analyzed. After 8 weeks of double-blind treatment, the mean (SD) changes in SitSBP at 8 weeks were −16.4 (0.9) mm Hg and −6.9 (1.0) mm Hg in the A/L/C and A/L groups, respectively. A/L/C had a statistically superior blood pressure–lowering effect compared with that of A/L (mean [SD] difference, 9.5 [1.3] mm Hg; P < 0.001). The mean (SD) change in SitDBP at 8 weeks was significantly greater with A/L/C (−8.0 [0.6] mm Hg) than with A/L (−3.6 [0.6] mm Hg) (P <.001). In terms of the mean (SD) change in SitDBP at 2 weeks compared with baseline, A/L/C (−5.9 [0.5] mm Hg) was statistically different from A/L (−2.9 [0.5] mm Hg) (P <.001). Mean (SD) SitSBP change from baseline to week 2 was −13.2 (0.9) and −5.5 (0.9) in the A/L/C and A/L groups, respectively, with a statistically significant blood pressure–lowering effect (P < 0.001). The number of participants who achieved target blood pressure at week 8 was significantly higher in the A/L/C group (93 patients [55.7{\%}]) than in the A/L group (48 [29.8{\%}]) (P < 0.001). Adverse drug reactions were observed in 23 patients (7.0{\%}), and the incidence of dizziness was significantly higher in the A/L/C group than in the A/L group (4.8{\%} vs 0.6{\%}, P = 0.037) There were no serious adverse events associated with the study drugs. Implications The results of this study suggest that A/L/C had a significantly increased blood pressure–lowering efficacy compared with that of A/L and had a good safety profile. ClinicalTrials.gov identifier: NCT02916602.",
author = "Hong, {Soon Jun} and Jeong, {Han Saem} and Han, {Seung Hwan} and Chang, {Ki Yuk} and Hong, {Bum Kee} and Lee, {Bong Ki} and Chae, {Shung Chull} and Kim, {Woo Shik} and Park, {Chang Gyu} and Heo, {Jung Ho} and Lee, {Seung Uk} and Kim, {Young Dae} and Kim, {Kee Sik} and Choi, {Jung Hyun} and Kang, {Hyun Jae} and Kim, {Jae Joong} and Kang, {Seok Min} and Choi, {Young Jin} and Shin, {Joon Han} and Chun, {Kook Jin} and Shin, {Dong Gu} and Park, {Seong Hoon} and Jun Kwan and Choi, {Yu Jeong} and Jeong, {Myung Ho} and Chae, {Jei Keon} and Kim, {Dong Woon} and Cho, {Jung Rae} and Han, {Kyoo Rok} and Won, {Kyung Heon} and Park, {Sang Ho} and Lee, {Sang Kon} and Kim, {Sang Hoon} and Jina Jung and Kim, {Cheol Ho}",
year = "2017",
month = "10",
doi = "10.1016/j.clinthera.2017.08.013",
language = "English",
volume = "39",
pages = "2049--2060",
journal = "Clinical Therapeutics",
issn = "0149-2918",
publisher = "Excerpta Medica",
number = "10",

}

Hong, SJ, Jeong, HS, Han, SH, Chang, KY, Hong, BK, Lee, BK, Chae, SC, Kim, WS, Park, CG, Heo, JH, Lee, SU, Kim, YD, Kim, KS, Choi, JH, Kang, HJ, Kim, JJ, Kang, SM, Choi, YJ, Shin, JH, Chun, KJ, Shin, DG, Park, SH, Kwan, J, Choi, YJ, Jeong, MH, Chae, JK, Kim, DW, Cho, JR, Han, KR, Won, KH, Park, SH, Lee, SK, Kim, SH, Jung, J & Kim, CH 2017, 'Comparison of Fixed-dose Combinations of Amlodipine/Losartan Potassium/Chlorthalidone and Amlodipine/Losartan Potassium in Patients With Stage 2 Hypertension Inadequately Controlled With Amlodipine/Losartan Potassium: A Randomized, Double-blind, Multicenter, Phase III Study', Clinical Therapeutics, vol. 39, no. 10, pp. 2049-2060. https://doi.org/10.1016/j.clinthera.2017.08.013

Comparison of Fixed-dose Combinations of Amlodipine/Losartan Potassium/Chlorthalidone and Amlodipine/Losartan Potassium in Patients With Stage 2 Hypertension Inadequately Controlled With Amlodipine/Losartan Potassium : A Randomized, Double-blind, Multicenter, Phase III Study. / Hong, Soon Jun; Jeong, Han Saem; Han, Seung Hwan; Chang, Ki Yuk; Hong, Bum Kee; Lee, Bong Ki; Chae, Shung Chull; Kim, Woo Shik; Park, Chang Gyu; Heo, Jung Ho; Lee, Seung Uk; Kim, Young Dae; Kim, Kee Sik; Choi, Jung Hyun; Kang, Hyun Jae; Kim, Jae Joong; Kang, Seok Min; Choi, Young Jin; Shin, Joon Han; Chun, Kook Jin; Shin, Dong Gu; Park, Seong Hoon; Kwan, Jun; Choi, Yu Jeong; Jeong, Myung Ho; Chae, Jei Keon; Kim, Dong Woon; Cho, Jung Rae; Han, Kyoo Rok; Won, Kyung Heon; Park, Sang Ho; Lee, Sang Kon; Kim, Sang Hoon; Jung, Jina; Kim, Cheol Ho.

In: Clinical Therapeutics, Vol. 39, No. 10, 10.2017, p. 2049-2060.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Comparison of Fixed-dose Combinations of Amlodipine/Losartan Potassium/Chlorthalidone and Amlodipine/Losartan Potassium in Patients With Stage 2 Hypertension Inadequately Controlled With Amlodipine/Losartan Potassium

T2 - A Randomized, Double-blind, Multicenter, Phase III Study

AU - Hong, Soon Jun

AU - Jeong, Han Saem

AU - Han, Seung Hwan

AU - Chang, Ki Yuk

AU - Hong, Bum Kee

AU - Lee, Bong Ki

AU - Chae, Shung Chull

AU - Kim, Woo Shik

AU - Park, Chang Gyu

AU - Heo, Jung Ho

AU - Lee, Seung Uk

AU - Kim, Young Dae

AU - Kim, Kee Sik

AU - Choi, Jung Hyun

AU - Kang, Hyun Jae

AU - Kim, Jae Joong

AU - Kang, Seok Min

AU - Choi, Young Jin

AU - Shin, Joon Han

AU - Chun, Kook Jin

AU - Shin, Dong Gu

AU - Park, Seong Hoon

AU - Kwan, Jun

AU - Choi, Yu Jeong

AU - Jeong, Myung Ho

AU - Chae, Jei Keon

AU - Kim, Dong Woon

AU - Cho, Jung Rae

AU - Han, Kyoo Rok

AU - Won, Kyung Heon

AU - Park, Sang Ho

AU - Lee, Sang Kon

AU - Kim, Sang Hoon

AU - Jung, Jina

AU - Kim, Cheol Ho

PY - 2017/10

Y1 - 2017/10

N2 - Purpose The goal of this study was to compare the efficacy and safety of fixed-dose combinations of amlodipine/losartan potassium/chlorthalidone (A/L/C) and A/L in Korean patients with stage 2 hypertension inadequately controlled by A/L. Methods This study was an 8-week, randomized double-blind, multicenter, phase III clinical trial. Three hundred forty volunteer patients with stage 2 hypertension were randomized to receive A/L/C or A/L. The primary end point was a change in sitting systolic blood pressure (SitSBP) after 8 weeks of treatment. As secondary end points, the change in SitSBP after 2 weeks of treatment and the change in sitting diastolic blood pressure (SitDBP) were compared between treatment groups. All patients were assessed for adverse events, clinical laboratory data, and vital signs. Findings Of 330 patients from 33 medical centers, 328 patients who had available efficacy data were analyzed. After 8 weeks of double-blind treatment, the mean (SD) changes in SitSBP at 8 weeks were −16.4 (0.9) mm Hg and −6.9 (1.0) mm Hg in the A/L/C and A/L groups, respectively. A/L/C had a statistically superior blood pressure–lowering effect compared with that of A/L (mean [SD] difference, 9.5 [1.3] mm Hg; P < 0.001). The mean (SD) change in SitDBP at 8 weeks was significantly greater with A/L/C (−8.0 [0.6] mm Hg) than with A/L (−3.6 [0.6] mm Hg) (P <.001). In terms of the mean (SD) change in SitDBP at 2 weeks compared with baseline, A/L/C (−5.9 [0.5] mm Hg) was statistically different from A/L (−2.9 [0.5] mm Hg) (P <.001). Mean (SD) SitSBP change from baseline to week 2 was −13.2 (0.9) and −5.5 (0.9) in the A/L/C and A/L groups, respectively, with a statistically significant blood pressure–lowering effect (P < 0.001). The number of participants who achieved target blood pressure at week 8 was significantly higher in the A/L/C group (93 patients [55.7%]) than in the A/L group (48 [29.8%]) (P < 0.001). Adverse drug reactions were observed in 23 patients (7.0%), and the incidence of dizziness was significantly higher in the A/L/C group than in the A/L group (4.8% vs 0.6%, P = 0.037) There were no serious adverse events associated with the study drugs. Implications The results of this study suggest that A/L/C had a significantly increased blood pressure–lowering efficacy compared with that of A/L and had a good safety profile. ClinicalTrials.gov identifier: NCT02916602.

AB - Purpose The goal of this study was to compare the efficacy and safety of fixed-dose combinations of amlodipine/losartan potassium/chlorthalidone (A/L/C) and A/L in Korean patients with stage 2 hypertension inadequately controlled by A/L. Methods This study was an 8-week, randomized double-blind, multicenter, phase III clinical trial. Three hundred forty volunteer patients with stage 2 hypertension were randomized to receive A/L/C or A/L. The primary end point was a change in sitting systolic blood pressure (SitSBP) after 8 weeks of treatment. As secondary end points, the change in SitSBP after 2 weeks of treatment and the change in sitting diastolic blood pressure (SitDBP) were compared between treatment groups. All patients were assessed for adverse events, clinical laboratory data, and vital signs. Findings Of 330 patients from 33 medical centers, 328 patients who had available efficacy data were analyzed. After 8 weeks of double-blind treatment, the mean (SD) changes in SitSBP at 8 weeks were −16.4 (0.9) mm Hg and −6.9 (1.0) mm Hg in the A/L/C and A/L groups, respectively. A/L/C had a statistically superior blood pressure–lowering effect compared with that of A/L (mean [SD] difference, 9.5 [1.3] mm Hg; P < 0.001). The mean (SD) change in SitDBP at 8 weeks was significantly greater with A/L/C (−8.0 [0.6] mm Hg) than with A/L (−3.6 [0.6] mm Hg) (P <.001). In terms of the mean (SD) change in SitDBP at 2 weeks compared with baseline, A/L/C (−5.9 [0.5] mm Hg) was statistically different from A/L (−2.9 [0.5] mm Hg) (P <.001). Mean (SD) SitSBP change from baseline to week 2 was −13.2 (0.9) and −5.5 (0.9) in the A/L/C and A/L groups, respectively, with a statistically significant blood pressure–lowering effect (P < 0.001). The number of participants who achieved target blood pressure at week 8 was significantly higher in the A/L/C group (93 patients [55.7%]) than in the A/L group (48 [29.8%]) (P < 0.001). Adverse drug reactions were observed in 23 patients (7.0%), and the incidence of dizziness was significantly higher in the A/L/C group than in the A/L group (4.8% vs 0.6%, P = 0.037) There were no serious adverse events associated with the study drugs. Implications The results of this study suggest that A/L/C had a significantly increased blood pressure–lowering efficacy compared with that of A/L and had a good safety profile. ClinicalTrials.gov identifier: NCT02916602.

UR - http://www.scopus.com/inward/record.url?scp=85029596842&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85029596842&partnerID=8YFLogxK

U2 - 10.1016/j.clinthera.2017.08.013

DO - 10.1016/j.clinthera.2017.08.013

M3 - Article

C2 - 28939406

AN - SCOPUS:85029596842

VL - 39

SP - 2049

EP - 2060

JO - Clinical Therapeutics

JF - Clinical Therapeutics

SN - 0149-2918

IS - 10

ER -